Moderna’s Combined Flu and COVID-19 Vaccine Receives Positive EMA Recommendation

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for mCOMBRIAX (mRNA-1083), Moderna’s combined vaccine for influenza and COVID-19 in individuals aged 50 years and older. This marks a significant milestone in respiratory virus vaccination and represents Moderna’s fourth potential product to be marketed in Europe. Source

What is mCOMBRIAX?

mCOMBRIAX is a novel vaccine developed by Moderna that combines protection against both influenza and COVID-19 in a single dose. It builds upon the technology behind Moderna’s existing COVID-19 vaccine, mNEXSPIKE, and its investigational seasonal influenza vaccine, mRNA-1010. Source mRNA-1010 is currently under review by regulatory authorities in the United States, the European Union, Canada, and Australia.

Clinical Trial Results

The CHMP’s positive opinion is supported by data from a pivotal Phase 3 clinical trial. This randomized, blinded, and active-controlled study evaluated the safety, reactogenicity, and immunogenicity of mRNA-1083 in approximately 4,000 adults in two age groups. Source

• 65 Years and Older Group: Compared mRNA-1083 to the co-administration of Fluzone HD (marketed as Efluelda in the EU), a high-dose influenza vaccine, and Spikevax, Moderna’s authorized COVID-19 vaccine.
• 50-64 Years Group: Compared mRNA-1083 to the co-administration of Fluarix, a standard-dose influenza vaccine, and Spikevax.

The trial met all primary endpoints, demonstrating non-inferiority in immune responses. A single dose of mRNA-1083 induced significantly higher immune responses against three influenza strains (A/H1N1, A/H3N2, and B/Victoria) and SARS-CoV-2 in both age groups. Source

The B/Yamagata strain, which is no longer recommended for inclusion in seasonal flu vaccines, was the only strain for which a significantly superior immune response was not observed in adults aged 65 and older compared to the authorized comparator vaccines.

Safety and Tolerability

mRNA-1083 demonstrated an acceptable safety and tolerability profile. The most frequent adverse reactions were Grade 1 or 2 in intensity and were similar to those observed with the authorized vaccines used in the trial. Source

What’s Next?

Following the CHMP’s positive opinion, the European Commission will review the recommendation and develop a final decision regarding marketing authorization. Moderna plans to collaborate with regulatory and national health authorities to support access and implementation at the local level. Source

Stéphane Bancel, Chief Executive Officer of Moderna, highlighted the advantages of combination vaccines, noting that they simplify the vaccination process. Source